# K222361: AI-Rad Companion (Musculoskeletal)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 20, 2022 after 77 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K954678 (1996). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193267: Al-Rad Companion (Musculoskeletal), Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Indications for use
AI-Rad Companion (Musculoskeletal) is an image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of musculoskeletal disease. It provides the following functionality: • Segmentation of vertebras • Labelling of vertebras • Measurements of heights in each vertebra and indication if they are critically different • Measurement of mean Hounsfield value in volume of interest within vertebra. Only DICOM images of adult patients are considered to be valid input.

Source page: https://510kreport.com/device/K222361
Methodology: https://510kreport.com/methodology